CTD文件格式总目录

CTD文件格式总目录
Table of contents
一、organization
二、M4Q(R1)
三、M4S（R2）
四、M4E(R1)
一、Organization组织结构
（一）ORGANISATION OF THE COMMON TECHNICAL DOCUMENT Module 1: Administrative Information and Prescribing Information
1.1 Table of Contents of the Submission Including Module 1
1.2 Documents Specific to Each Region (for example, application forms,
prescribing information)
Module 2: Common Technical Document Summaries
2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
Pharmacology
Pharmacokinetics
Toxicology
2.7 Clinical Summary
Biopharmaceutic Studies and Associated Analytical Methods
Clinical Pharmacology Studies
Clinical Efficacy
Clinical Safety
Literature References
Synopses of Individual Studies
Module 3: Quality
3.1 Table of Contents of Module 3
3.2 Body of Data
3.3 Literature References
Module 4: Nonclinical Study Reports
4.1 Table of Contents of Module 4
4.2 Study Reports
4.3 Literature References
Module 5: Clinical Study Reports
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.4 Literature References
（二）该部分文件还附带有Granularity Document
二、M4Q(R1)质量部分
TABLE OF CONTENTS
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES
2.3 : QUALITY OVERALL SUMMARY (QOS) 质量总体概述
INTRODUCTION简介
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)药用物质部分
2.3.S.1 General Information (name, manufacturer)
2.3.S.2 Manufacture (name, manufacturer)
2.3.S.3 Characterisation (name, manufacturer)
2.3.S.4 Control of Drug Substance (name, manufacturer)
2.3.S.5 Reference Standards or Materials (name, manufacturer)
2.3.S.6 Container Closure System (name, manufacturer)
2.3.S.7 Stability (name, manufacturer)
2.3.P DRUG PRODUCT (NAME, DOSAGE FORM)制剂部分
2.3.P.1 Description and Composition of the Drug Product (name, dosage form)
2.3.P.2 Pharmaceutical Development (name, dosage form)研发
2.3.P.3 Manufacture (name, dosage form)生产
2.3.P.4 Control of Excipients (name, dosage form)辅料控制
2.3.P.5 Control of Drug Product (name, dosage form) 制剂控制
2.3.P.6 Reference Standards or Materials (name, dosage form) 标准品或物料
2.3.P.7 Container Closure System (name, dosage form) 容器密闭系统
2.3.P.8 Stability (name, dosage form)稳定性
2.3.A APPENDICES附录
2.3.A.1 Facilities and Equipment (name, manufacturer)设施和设备
2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)外源性试剂安全性评价
2.3.A.3 Excipients辅料
2.3.R REGIONAL INFORMATION区域性信息
MODULE 3 : QUALITY
3.1. TABLE OF CONTENTS OF MODULE 3
3.2. BODY OF DATA
3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)
3.2.S.1 General Information (name, manufacturer)
3.2.S.1.1 Nomenclature (name, manufacturer)
3.2.S.1.2 Structure (name, manufacturer)
3.2.S.1.3 General Properties (name, manufacturer)
3.2.S.2 Manufacture (name, manufacturer)
3.2.S.2.1 Manufacturer(s) (name, manufacturer)
3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer)
3.2.S.2.3 Control of Materials (name, manufacturer)
3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer)
3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)
3.2.S.2.6 Manufacturing Process Development (name, manufacturer)工艺开发
3.2.S.3 Characterisation (name, manufacturer)
3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer)
3.2.S.3.2 Impurities (name, manufacturer)
3.2.S.4 Control of Drug Substance (name, manufacturer)
3.2.S.
4.1 Specification (name, manufacturer)
3.2.S.
4.2 Analytical Procedures (name, manufacturer)
3.2.S.
4.3 Validation of Analytical Procedures (name, manufacturer)
3.2.S.
4.4 Batch Analyses (name, manufacturer)
3.2.S.5 Reference Standards or Materials (name, manufacturer)
3.2.S.6 Container Closure System (name, manufacturer)
3.2.S.7 Stability (name, manufacturer)
3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer)
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer)
3.2.S.7.3 Stability Data (name, manufacturer)
3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)
3.2.P.1 Description and Composition of the Drug Product (name, dosage form) The Common Technical Document – Quality
3.2.P.2 Pharmaceutical Development (name, dosage form)
3.2.P.2.1 Components of the Drug Product (name, dosage form)
3.2.P.2.1.1 Drug Substance (name, dosage form)
3.2.P.2.1.2 Excipients (name, dosage form)
3.2.P.2.2 Drug Product (name, dosage form)
3.2.P.2.2.1 Formulation Development (name, dosage form)
3.2.P.2.2.2 Overages (name, dosage form)
3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)
3.2.P.2.3 Manufacturing Process Development (name, dosage form)
3.2.P.2.4 Container Closure System (name, dosage form)
3.2.P.2.5 Microbiological Attributes (name, dosage form)
3.2.P.2.6 Compatibility (name, dosage form)
3.2.P.3 Manufacture (name, dosage form)
3.2.P.3.1 Manufacturer(s) (name, dosage form)
3.2.P.3.2 Batch Formula (name, dosage form)
3.2.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)
3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)
3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)
3.2.P.4 Control of Excipients (name, dosage form)
3.2.P.
4.1 Specifications (name, dosage form)
3.2.P.
4.2 Analytical Procedures (name, dosage form)
3.2.P.
4.3 Validation of Analytical Procedures (name, dosage form)
3.2.P.
4.5 Excipients of Human or Animal Origin (name, dosage form)
3.2.P.
4.6 Novel Excipients (name, dosage form)
3.2.P.5 Control of Drug Product (name, dosage form)
3.2.P.5.1 Specification(s) (name, dosage form)
3.2.P.5.2 Analytical Procedures (name, dosage form)
3.2.P.5.3 Validation of Analytical Procedures (name, dosage form).
3.2.P.5.4 Batch Analyses (name, dosage form)
3.2.P.5.5 Characterisation of Impurities (name, dosage form)
3.2.P.5.6 Justification of Specification(s) (name, dosage form)
3.2.P.6 Reference Standards or Materials (name, dosage form)
3.2.P.7 Container Closure System (name, dosage form)
3.2.P.8 Stability (name, dosage form)
3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name, dosage form)
3.2.P.8.3 Stability Data (name, dosage form)
3.2.A APPENDICES
3.2.A.1 Facilities and Equipment (name, manufacturer)
3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)
3.2.A.3 Excipients
3.2.R REGIONAL INFORMATION
3.3 LITERATURE REFERENCES
三、M4S（R2）安全性部分
TABLE OF CONTENTS
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES
General Principles of Nonclinical Overview and Summaries
2.4 NONCLINICAL OVERVIEW
General Aspects
Content and Structural Format
2.6 NONCLINICAL WRITTEN AND TABULATED SUMMARIES
Nonclinical Written Summaries
Introduction
General Presentation Issues
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.2.1 Brief Summary
2.6.2.2 Primary Pharmacodynamics
2.6.2.3 Secondary Pharmacodynamics
2.6.2.4 Safety Pharmacology
2.6.2.5 Pharmacodynamic Drug Interactions
2.6.2.6 Discussion and Conclusions
2.6.2.7 Tables and Figures
2.6.3 Pharmacology Tabulated Summary (see Appendix B)
2.6.4 Pharmacokinetics Written Summary
2.6.4.1 Brief Summary
2.6.4.2 Methods of Analysis
2.6.4.3 Absorption
2.6.4.4 Distribution
2.6.4.5 Metabolism (interspecies comparison)
2.6.4.6 Excretion
2.6.4.7 Pharmacokinetic Drug Interactions
2.6.4.8 Other Pharmacokinetic Studies
2.6.4.9 Discussion and Conclusions
2.6.4.10 Tables and Figures
2.6.5 Pharmacokinetics Tabulated Summary (see Appendix B)
2.6.6 Toxicology Written Summary
2.6.6.1 Brief Summary
2.6.6.2 Single-Dose Toxicity
2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)
2.6.6.4 Genotoxicity
2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations)
2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)
2.6.6.7 Local Tolerance
2.6.6.8 Other Toxicity Studies (if available)
2.6.6.9 Discussion and Conclusions
2.6.6.10 Tables and Figures
2.6.7 Toxicology Tabulated Summary (see Appendix B)
MODULE 4: NONCLINICAL STUDY REPORTS
4.1 Table of Contents of Module 4
4.2 Study Reports
4.3 Literature References
APPENDIX A
Examples of Tables and Figures for Written Summaries APPENDIX B
The Nonclinical Tabulated Summaries - Templates
APPENDIX C
The Nonclinical Tabulated Summaries – Examples
四、M4E(R1)有效性部分
TABLE OF CONTENTS
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 2.5: CLINICAL OVERVIEW
Preamble
Table of Contents
Detailed Discussion of Content of the Clinical Overview Sections
2.5.1 Product Development Rationale
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety..
2.5.6 Benefits and Risks Conclusions
2.5.7 Literature References
2.7 : CLINICAL SUMMARY
Preamble
Table of Contents
Detailed Guidance on Sections of the Clinical Summary
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
2.7.1.1 Background and Overview
2.7.1.2 Summary of Results of Individual Studies
2.7.1.3 Comparison and Analyses of Results Across Studies
2.7.1.4 Appendix
2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview
2.7.2.2 Summary of Results of Individual Studies
2.7.2.3 Comparison and Analyses of Results Across Studies
2.7.2.4 Special Studies
2.7.2.5 Appendix
2.7.3 Summary of Clinical Efficacy
2.7.
3.1 Background and Overview of Clinical Efficacy
2.7.
3.2 Summary of Results of Individual Studies
2.7.
3.3 Comparison and Analyses of Results Across Studies
2.7.
3.3.1 Study Populations
2.7.
3.3.2 Comparison of Efficacy Results of all Studies
2.7.
3.3.3 Comparison of Results in Sub-populations
2.7.
3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
2.7.
3.5 Persistence of Efficacy and/or Tolerance Effects
2.7.
3.6 Appendix
2.7.4 Summary of Clinical Safety
2.7.4.1 Exposure to the Drug
2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies
2.7.4.1.2 Overall Extent of Exposure
2.7.4.1.3 Demographic and Other Characteristics of Study Population
2.7.4.2 Adverse Events
2.7.4.2.1 Analysis of Adverse Events
2.7.4.2.2 Narratives
2.7.4.3 Clinical Laboratory Evaluations
2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety
2.7.4.5 Safety in Special Groups and Situations
2.7.4.5.1 Intrinsic Factors
2.7.4.5.2 Extrinsic Factors
2.7.4.5.3 Drug Interactions
2.7.4.5.4 Use in Pregnancy and Lactation
2.7.4.5.5 Overdose
2.7.4.5.6 Drug Abuse
2.7.4.5.7 Withdrawal and Rebound
2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability
2.7.4.6 Post-marketing Dat
2.7.4.7 Appendix
2.7.5 Literature References
2.7.6 Synopses of Individual Studies
MODULE 5 : CLINICAL STUDY REPORTS
Preamble
Detailed Organisation of Clinical Study Reports and Related Information in Module 5
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutic Studies
5.3.1.1 Bioavailability (BA) Study Reports.
5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports
5.3.1.3 In Vitro – In Vivo Correlation Study Reports
5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports
5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies
5.3.2.3 Reports of Studies Using Other Human Biomaterials
5.3.3 Reports of Human Pharmacokinetic (PK) Studies
5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports
5.3.3.2 Patient PK and Initial Tolerability Study Reports
5.3.3.3 Intrinsic Factor PK Study Reports
5.3.3.4 Extrinsic Factor PK Study Reports
5.3.3.5 Population PK Study Reports
5.3.4 Reports of Human Pharmacodynamic (PD) Studies
5.3.4.1 Healthy Subject PD and PK/PD Study Reports
5.3.4.2 Patient PD and PK/PD Study Reports
5.3.5 Reports of Efficacy and Safety Studies
5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
5.3.5.2 Study Reports of Uncontrolled Clinical Studies
5.3.5.3 Reports of Analyses of Data from More than One Study
5.3.5.4 Other Study Reports
5.3.6 Reports of Post-Marketing Experience
5.3.7 Case Report Forms and Individual Patient Listings
5.4 Literature References。